Photonova Spectra, Photonova Spectra Select
Summary
Ge Medical Systems, LLC received 510(k) clearance for Photonova Spectra, Photonova Spectra Select, a JAK device. Cleared on 2026-03-20.
Details
Source
510(k) Clearance
External ID
K253520
Action Date
2026-03-20
Status
Traditional
Category
device
Product Code
JAK
Product Description
Photonova Spectra, Photonova Spectra Select. Product code: JAK.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Ge Medical Systems, LLC has received 17 total clearances in our database.
Ge Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Ge Medical Systems, LLC have FDA actions?
Ge Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K253520" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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